Healthy adult dosing begins in Phase 1 trial of HL192 for Parkinson’s

Therapy targeting key dopaminergic neuron protein may be disease modifying

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by Andrea Lobo |

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A first healthy volunteer has been dosed in a Phase 1 clinical trial assessing the safety and tolerability of HL192, an investigational therapy for Parkinson’s disease.

The treatment, given orally, is designed to activate Nurr1, a key protein that regulates the development and maintenance of dopaminergic neurons. These nerve cells produce the chemical messenger dopamine, and they are progressively lost over the disease’s course.

Initial trial findings are expected in the second half of 2024, and if promising, a study in patients is intended.

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Early Parkinson’s clinical trial into HL192’s safety and tolerability

NurrOn Pharmaceuticals began work on the potential treatment, under the name ATH-399A, and then partnered this year with HanAll Biopharma and Daewoong Pharmaceutical, both based in South Korea, to continue developing HL192.

Our three firms “share the common goal of developing transformative treatments for [Parkinson’s disease],” Sean Jeong, MD, HanAll Biopharma’s CEO, said in a company press release. “Today, we stand at a significant juncture, having achieved the start of our first-in-human trial for HL192.”

Available Parkinson’s treatments mainly target disease symptoms, but they often lose effectiveness over time. They also are associated with such side effects as dyskinesia, or involuntary uncontrolled movements.

A high unmet need remains for therapies that can slow disease progression by targeting its underlying mechanisms.

HL192 has been shown to improve behavioral deficits in rat and mouse models of Parkinson’s disease, demonstrating its potential as a disease-modifying treatment without detectable signs of dyskinesia, NurrOn’s reports on its website.

By activating Nurr1, HL192 is expected to increase dopamine production while preventing the activation of pro-inflammatory genes in microglia, the brain’s primary immune cells. This dual action may slow disease progression and ease its symptoms.

The Phase 1 trial, supported by a grant from The Michael J. Fox Foundation (MJFF), is recruiting healthy adults, ages 18 to 80. It will assess the safety, tolerability, effects with food, and pharmacokinetics — how the body absorbs, distributes, metabolizes, and eliminates a medicine — of single and multiple doses of HL192. Further information, including the study’s location, was not available.

“MJFF is committed to fulfilling the unmet needs of people with Parkinson’s disease by funding therapeutic research,” said Katharina Klapper, PhD, director of clinical research at MJFF. “The Foundation is pleased to award a grant to NurrOn to develop a treatment aimed at the core biology of Parkinson’s.”

“We are excited to begin the first step in the clinical development of [HL192]. We look forward to completing the healthy participant study and advancing [HL192] for a Phase 2 study in [Parkinson’s disease] patients,” added Deog Joong Kim, PhD, NurrOn Pharmaceuticals’ CEO.

The South Korean companies also are working with NurrOn to study HL192’s potential in treating other neurodegenerative diseases.